A Randomized Trial of Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction Patients With High Thrombus Burden
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Rate of major adverse cardiovascular events (MACEs)
研究概览
简要总结
This is an multicenter, randomized, controlled, parallel group study. ST-Segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(HTB) will be allocated to one of the following: intrathrombus thrombolysis or manual aspiration thrombectomy during primary percutaneous coronary intervention(PPCI).
详细描述
The hypothesis for ATTRACTIVE trial is that the intrathrombus thrombolysis with microcatheter or pierced balloon compared to manual aspiration thrombectomy will reduce the incidence of major adverse cardiovascular events(MACEs), including cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure rehospitalization, stent thrombosis and target-vessel revascularization at 1 year in STEMI patients with HTB undergoing PPCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with:
- •Symptoms of myocardial ischemia lasting for ≥ 30 minutes AND
- •Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads
- •Referred for PPCI
- •Within 12 hours of symptom onset, or 12-24 hours but still suffered from persistent symptom, hemodynamic instability or fatal arrhythmia
- •High thrombus burden:
- •TIMI thrombus grade 3 or 4 after emergency coronary angiography
- •Or TIMI thrombus grade ≥3 after guidewire crossing or 1.5mm-diameter predilating the culprit lesion if emergency coronary angiography shows TIMI thrombus grade 5
- •Informed consent
排除标准
- •Rescue PCI after systemic thrombolysis
- •Previous CABG history
- •Life expectancy<1 year
- •Active bleeding in past 6 months, hemorrhagic disorders and prone to bleeding
- •Serious hepatic or kidney dysfunction
- •Pregnancy and lactation
- •Uncontrolled hypertension (>180/100mmHg)
- •Previous hemorrhagic stroke or ischemic stroke in past 3 months
- •Cardiogenic shock or cardio-pulmonary resuscitation
- •Informed consent cannot be obtained or follow-up cannot be completed
结局指标
主要结局
Rate of major adverse cardiovascular events (MACEs)
时间窗: up to 180 days
Rate of composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure readmission, stent thrombosis and target-vessel revascularization
次要结局
- Rate of ischemic stroke and transient ischemic attack (TIA)(up to 30 days)
- Rate of key net benefit outcome(up to 1 year)
- Rate of major bleeding evens (BARC type 2, 3 and 5)(up to 30 days)
研究者
Jingang Zheng
Director of Cardiology
China-Japan Friendship Hospital